NSF/ANSI Standards Green Chemistry and Commerce Council Roundtable Portland, Oregon July 10, 2008 Clif McLellan Director of Toxicology Services
Overview of Presentation Introduction to NSF International Introduction to American National Standards Institute (ANSI) Why an ANSI Standard? Challenges of the ANSI Standards Process as it relates to Green Chemistry 2
NSF Was Established In 1944 To Develop Standards, And Test And Certify Food Equipment. 3 public health experts found the National Sanitation Foundation (NSF) in the University of Michigan s School of Public Health 60 years ago. 3
Our Mission Has Always Focused On Protection Of Public Health And Safety. NSF International, an independent, not-for-profit non-governmental organization, is dedicated to being the leading global provider of public health and safety-based risk management solutions while serving the interests of all stakeholders.
NSF International Recognized world leader in standards development, product testing, certification and risk assessment Developed more than 72 national consensus standards Service provider to over 12,000 companies in 100 countries Certified more than 225,000 products around the globe 5
NSF Standards and Programs 6 1944 Food Service Equipment (22) 1956 Plastics and Plumbing System Components (3) 1960 Pools, Spas, Hot Tub Circulation Systems (1) 1965 Wastewater Unit Certification Program (3) 1971 Drinking Water Treatment Units (6) 1976 Biohazard Cabinetry (1) 1984 Bottled Water (Regulation-USFDA, EC80777) 1984 Drinking Water Laboratory Accreditation 1985 Drinking Water Additives 1999 Non-Food Compound Registration 2001 Dietary Supplements 2005 Athletic Banned Substances 2006 Green Chemistry 2007 ISO 21469 Certification 2008 Toy Safety
NSF Joint Committee: Consensus body that oversees a specific standard or set of related standards Regulators EPA, FDA, Health Canada, State and Local Government Manufacturers Producers and Trade Associations Users Consumers, Government Specifies, Consultants Certifiers, Testing Labs, Retailers and NGOs
What is a Consensus Standard? Consensus means substantial agreement has been reached by directly and materially affected interest categories. This signifies the concurrence of more than a simple majority, but not necessarily unanimity. Consensus requires that all views and objections be considered, and that an effort be made toward their resolution. ANSI Essential Requirements, 2008 8
Evidence of Consensus Maintain documentation and reporting of the consensus body vote Record and consider all negative votes accompanied by any comments related to the proposal under consideration Maintain written records of evidence regarding a change to an original vote 9
JC Balloting Requirements Affirmative ballot of at least 2/3 of those who voted, excluding abstentions Affirmative ballots must represent at least a simple majority of the JC membership (> 50%) All negative votes or comments have been considered 10
US Standardization System American National Standards Institute (ANSI) A private, non-profit organization that administers and coordinates the U.S. voluntary standardization and conformity assessment systems in the private sector Decentralized system ANSI roles ISO member body for United States Accreditation of Standard Development Organization including their programs, personnel, and laboratories Process review for voluntary standards development 11
Accreditation of Third-Party Certifiers Organizational and operational structures Certification body personnel qualifications Procedures for granting, maintaining, suspending, and withdrawing certification Appeals, complaints and disputes Surveillance or monitoring requirements Use of licenses, certificates, and marks of conformity Quality systems internal audits, document control 12
Accreditation of Third-Party Certifiers ANSI audits against ISO Guide 65 and certifier s documented procedures and policies Accreditation is intended to ensure consistent and reliable operation of certification systems, facilitating their acceptance on a national and international basis, with the intention of furthering international trade 13
Why an ANSI Standard? ANSI process helps ensure the development of a single American National Standard that does not overlap or conflict with other American National Standards Use of an accredited, audited process enhances credibility of the resulting standard ANSI requirements ensure the opportunity for all affected stakeholders to participate in the standards development process ANSI standards must be reaffirmed or revised every five years 14
Challenges of the ANSI Standards Process as it relates to Green Chemistry Establishing a leadership Standard may be difficult. Criteria associated with how a mark is used is typically not part of the Standard but is included in the Certification Policies of the Certifier. Certification is the decision of the third party certifier and it would be difficult for DfE to maintain oversight of reviewers. Equity does not always exist between certifiers. Expertise is not a requirement within an ANSI Standard. 15
16 QUESTIONS??